Inverted leaflet prosthetic valve

ABSTRACT

Prosthetic valve embodiments are described herein that include a frame and a valve member mounted within the frame. The valve members can have a plurality of leaflets that are affixed to one another along their inflow edges, with articulating edges projecting from the inflow edges in the outflow direction. In an open configuration, the articulating edges can be collapsed radially inward by the forward flow of blood through the prosthetic valve, thereby creating a plurality of discrete flow areas between the frame and the inflow edges of the leaflets. In a closed configuration, the leaflets can be pushed radially outward by the reverse flow of blood, thereby closing the plurality of discrete flow areas.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/571,029, filed Dec. 15, 2014, which claims the benefit ofU.S. Provisional Application No. 61/917,032, filed Dec. 17, 2013, bothof which applications are incorporated herein by reference.

FIELD

This disclosure relates generally to prosthetic valves and methods forintroducing the prosthetic valves into the body.

BACKGROUND

Prosthetic valves have been used for many years to treat valvulardisorders. Native valves, including heart valves (such as the aortic,pulmonary, tricuspid, and mitral valves), serve critical functions inassuring the forward flow of an adequate supply of blood through thecardiovascular system. These valves can be rendered less effective bycongenital, inflammatory, or infectious conditions. Such damage to thevalves can result in serious cardiovascular compromise or death. Formany years the definitive treatment for such disorders was the surgicalrepair or replacement of the valve during open heart surgery, but suchsurgeries are prone to many complications.

Transvascular techniques have also been developed for introducing andimplanting a prosthetic valve using a flexible catheter in a manner thatis less invasive than open-heart surgery. For example, a prostheticvalve can be mounted in a crimped state on the end-portion of a flexiblecatheter and advanced through a blood vessel of the patient until theprosthetic valve reaches the implantation site. The prosthetic valve atthe catheter tip can then be expanded to its functional size at the siteof the defective native valve such as by inflating a balloon on whichthe prosthetic valve is mounted. Alternatively, the prosthetic valve canhave a resilient, self-expanding stent or frame that self-expands theprosthetic valve to its functional size when advanced from a deliverysheath at the distal end of the catheter.

Prosthetic valves generally consist of a cylindrical stent-like frameand leaflets. The leaflets typically have fixed, inflow edges that aresutured continuously along an interior circumference of the cylindricalframe. Blood flows through the prosthetic valve when all the leafletsopen and lie against the inner surface of the prosthetic valve frame,creating a single, circular channel. Conversely, the prosthetic valvecloses when the leaflets are deflected inwardly and coapt against eachother, similarly to a native heart valve. Unfortunately, prostheticvalves can suffer from paravalvular leaks (PVL), or blood leaking aroundthe outside of the prosthetic valve. A need therefore exists for astented bioprosthetic valve which minimizes PVL and/or other sources ofregurgitation through the prosthetic valve.

SUMMARY

Embodiments of prosthetic valves are described herein that include astent/frame and a valve member mounted within the frame. The valvemembers can comprise a plurality of leaflets, each with an articulatingedge and an inflow edge that extends across the stent/frame lumenbetween commissure tabs spaced angularly apart along an interiorcircumference of the frame. Adjacent leaflets can be affixed to oneanother along these inflow edges, with articulating edges projectingfrom the inflow edges in the outflow direction with the forward flow ofblood. In an open configuration, the leaflets can be collapsed radiallyinward by the forward flow of blood through the prosthetic valve,thereby creating a plurality of discrete flow areas between the frameand the inflow edges of the leaflets. In a closed configuration, thearticulating edges of the leaflets can be pushed radially outward by thereverse flow of blood, thereby closing the plurality of discrete flowareas.

In one aspect, a prosthetic valve is provided having a valve member andan annular frame with an inflow end, an outflow end, and a longitudinalaxis extending from the inflow end to the outflow end. The valve membercan be mounted within the annular frame and can comprise a plurality offlexible leaflets. The valve member can be located between the inflowend and the outflow end of the annular frame. Each leaflet can comprisean inflow surface, an outflow surface, a substantially non-articulatinginflow edge, and at least one articulating outflow edge. Adjacentleaflets can be affixed to one another along their respective inflowedges. In an open configuration, the leaflets can be collapsed radiallyinward by the forward flow of blood through the prosthetic valve,thereby creating a plurality of discrete flow areas between the frameand the inflow edges of the leaflets. In a closed configuration, theleaflets can be pushed radially outward by the reverse flow of blood,thereby closing the plurality of discrete flow areas.

In some embodiments, each of the inflow edges extend between two pointsspaced circumferentially apart an interior circumference of the frame.The inflow edges of the adjacent leaflets can be joined togetherdirectly without the aid of a mechanical support member extendingbetween the points.

In some embodiments, a pocket is formed between the leaflets, in theopen configuration, which faces the outflow end and is bordered by thearticulating edges and the outflow surfaces of the leaflets. In someembodiments, the pocket can be configured such that reverse flowentering into the pocket forces the leaflets radially outward.

In some embodiments, in the open configuration, the inflow edges and theleaflets together form a three-pointed star arrangement.

In some embodiments, in the closed configuration, the articulating edgesare in contact with the frame and/or a skirt lining an interior surfaceof the frame.

In some embodiments, in the closed configuration, the outflow surfacesface the outflow end of the prosthetic valve, and the inflow surfacesface the inflow end of the prosthetic valve.

In some embodiments, the annular frame is a collapsible and expandableannular frame that is configured to be collapsed to a radially collapsedstate for mounting on a delivery apparatus and expanded to a radiallyexpanded state inside the body.

In some embodiments, the inflow edges of the leaflets have outer edgeportions adjacent the frame, and the inflow edges define a central hub,which is at substantially the same longitudinal position relative to alongitudinal axis of the prosthetic valve as the outer edge portions.

In another aspect, a method of transmitting blood through a prostheticvalve is provided, comprising providing a prosthetic valve having aframe and a plurality of leaflets located between an inflow end and anoutflow end of the frame. Each leaflet can have an inflow surface, anoutflow surface, an inflow edge and at least one articulating outflowedge. The method further comprises collapsing the plurality of leafletsin a radially inward direction to permit the forward flow of bloodthrough the prosthetic valve; and expanding the leaflets radiallyoutward towards an interior surface of the frame to substantiallyprevent the reverse flow of blood through the prosthetic valve.

In some embodiments, a pocket is formed between the collapsed leaflets,wherein the pocket faces the outflow end.

In some embodiments, the expanding comprises causing the inflow surfacesto face the inflow end and causing the outflow surfaces to face theoutflow end.

In some embodiments, the expanding comprises causing at least one of thearticulating edges of each leaflet to contact the frame and/or a skirtlining an interior of the frame.

In some embodiments, the expanding comprises allowing reverse blood flowto enter into the pocket and force the leaflets radially outward.

In some embodiments, the collapsing creates multiple discrete flow areasbetween the leaflets and inside of the frame.

In another aspect, a method of implanting a prosthetic valve isprovided, comprising implanting into a patient's body a prosthetic valvehaving a frame and a plurality of leaflets located between an inflow endand an outflow end of the frame. A pressure gradient in a firstdirection can cause the plurality of leaflets of the prosthetic valve tocollapse radially inwardly to permit the forward flow of blood throughthe prosthetic valve, and a pressure gradient in a second direction cancause the plurality of leaflets to expand radially outward tosubstantially prevent the reverse flow of blood through the prostheticvalve.

In some embodiments, the pressure gradient in the second directioncauses inflow surfaces of the leaflets to face an inflow end of theprosthetic valve and outflow surfaces of the leaflets to face an outflowend of the prosthetic valve.

In some embodiments, the pressure gradient in the second directioncauses at least one articulating edge of each leaflet to contact a frameof the prosthetic valve and/or a skirt lining an interior of the frame.

In some embodiments, the expanding of the plurality of the leafletscomprises expanding a pocket formed between the leaflets, the pocketfacing the outflow end of the prosthetic valve.

In some embodiments, the radial collapsing of the plurality of leafletscreates multiple discrete flow areas between the leaflets.

The foregoing and other objects, features, and advantages of thedisclosed technology will become more apparent from the followingdetailed description, which proceeds with reference to the accompanyingfigures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of a prosthetic valve embodiment, in anopen configuration.

FIG. 2 is a side view of the prosthetic valve embodiment of FIG. 1, in aclosed configuration.

FIG. 3 is an outflow view of the prosthetic valve embodiment of FIG. 1,in an open configuration.

FIG. 4 is an inflow view of the prosthetic valve embodiment of FIG. 1,in an open configuration.

FIG. 5 is an outflow view of the prosthetic valve embodiment of FIG. 1,in a partially closed configuration.

FIG. 6 is an outflow view of the prosthetic valve embodiment of FIG. 1,in a closed configuration.

FIG. 7 is an inflow view of the prosthetic valve embodiment of FIG. 1,in a closed configuration.

FIG. 8 is a side elevation view of a leaflet assembly can be used in theprosthetic valve embodiment of FIG. 1, shown in an unrolled or flattenedconfiguration.

DETAILED DESCRIPTION

Prosthetic valve embodiments are disclosed herein having a stent/framedefining a lumen and plurality of leaflets that can flex inwardly toopen and flex outwardly to close. Rather than having contoured inflowedges that are sutured circumferentially to the frame, the leaflets caneach have inflow edges that extend out across the lumen, betweencommissure tabs spaced circumferentially apart along an interiorcircumference of the frame. Each inflow edge can be sutured (orotherwise attached) along its length to the inflow edge(s) of adjacentleaflet(s). Discrete flow areas can thus be created between each leafletinflow edge and the interior stent wall. Articulating edges of theleaflets can project from their respective inflow edges in the outflowdirection, with forward blood flow. The leaflets can thus move, betweenan open position and a closed position, in response to differences influid pressure between the inflow and outflow ends of the prostheticvalve.

When blood flows through the prosthetic valve from the inflow end in theoutflow direction, the leaflets can be pushed radially inward againstone another towards the center of the lumen, thereby defining discreteflow passages between the frame and the inflow edges of the leaflets.Reverse blood flow (from the outflow end in the inflow direction) canenter into a space between the leaflets (towards the center of thelumen) that faces the outflow end, pushing the articulating edges of theleaflets radially outward to close the prosthetic valve. In this closedconfiguration, the leaflets can effectively seal off various potentialleak paths to reverse flow, such as space(s) located between theleaflets and the skirt and/or any spaces between the leafletsthemselves.

While additional structural elements can optionally be included tocoordinate or otherwise assist in the radial movements of the leaflets,such additional elements are not necessary in the disclosed embodiments.Thus, in various embodiments, the leaflets can expand radially outwardto assume a closed configuration, and collapse inward to assume an openconfiguration, without the aid of mechanical arms, springs, struts, orother appendages. In particular, the inflow edges of the adjacentleaflets can be joined together directly without the aid of a mechanicalsupport member (such as an arm, strut, spring, or other appendage)extending between them (e.g., between two points spacedcircumferentially apart along an interior circumference of the frame).

The prosthetic valve 10 is adapted to be deployed in the native aorticannulus, although it also can be adapted to replace other native valvesof the heart (the mitral, pulmonary, and/or tricuspid valve). Moreover,the prosthetic valve 10 can be adapted to replace other valves withinthe body, such as venous valves.

Referring now to FIGS. 1-2, a prosthetic valve 10, according to oneembodiment, can comprise an annular frame or stent 12 having an inflowend 14 and an outflow end 16 defining a longitudinal axis Z (FIG. 1),and a skirt 18 mounted to the frame 12. The skirt 18 can be an annularskirt positioned inside of the frame 12 as shown. The skirt 18 cancomprise a fabric, tissue, membrane, or other material, and can insulatethe leaflets 20 from dilapidation or damage that may result from directcontact with the frame 12. If desired, an outer skirt (not shown) can besecured around the outside of the frame 12, for example, to facilitatesealing of the frame 12 against the native annulus and/or reduce damageto the native annulus. Some embodiments of an inner skirt and outerskirt are unitary, while other embodiments use two or more pieces ofmaterial.

Between the inflow and outflow ends 14, 16 of the prosthetic valve is avalve member comprising a plurality of flexible leaflets 20. As shown inFIGS. 3-5 and 7, each leaflet 20 can comprise two commissure tabs 22,spaced angularly apart along an interior circumference of the frame 12.The skirt 18 can be secured to the frame 12, such as with sutures 40.Each commissure tab 22 can be rolled up and connected to a commissuretab of an adjacent leaflet, such as by sutures, so as to definerespective commissures of the leaflets 20. The commissure tabs 22 canalso be sutured to the frame 12 and/or the skirt 18. As shown in thefigures, the prosthetic valve 10 can have a set of three leaflets 20 ina tricuspid arrangement. In other embodiments, the prosthetic valve 10can have a different number of leaflets, such as two leaflets (e.g., abicuspid arrangement) or four leaflets.

The leaflets 20 can each further comprise an inflow surface 24, anoutflow surface 26, an inflow edge 28 (FIGS. 4 and 7) extending betweenthe commissure tabs 22, and at least one articulating edge 30 (FIGS. 1,3 and 5). The articulating edges 30 can be configured to project fromthe inflow edges 28 in the direction of the outflow end 16 with theforward flow of blood. As shown in FIGS. 4 and 7, adjacent leaflets 20can be securely attached to each other in the vicinity of the respectiveinflow edges 28, such as by transverse sutures 36 (orthogonal to theinflow edges 28) and/or any other biocompatible adhesive known to thoseof skill in the art. The transverse sutures 36 may optionally beaccompanied by longitudinal sutures (in the direction of the inflowedges 28) (not shown). Thus, in various embodiments, the inflow edges 28are substantially non-articulating. As shown in FIGS. 4 and 7, theinflow edge 28 of each leaflet can be affixed to the inflow edges of theother two leaflets. In particular, adjacent inflow edges 28 can becovered by a reinforcing layer 38 to help secure the leaflets 20together, with sutures passing through the inflow edges 28 and thereinforcing layer 38. The reinforcing layer 38 can be, for example, afabric (e.g., woven polyethylene terephthalate (PET), DACRON®), a tissuelayer, or any of the various other materials that are used to form skirt18, as further described below.

The inflow edges 28 can each follow an angled course from the frame 12to the center of the prosthetic valve and back to the frame 12. As shown(for a prosthetic valve 10 having three leaflets 20), the angle definedby each leaflet 20 at the center of the prosthetic valve 10 can be about120°, and the total of all of these angles can be about 360°. In otherembodiments, the angled courses of the inflow edges differ from oneanother, but still add up to 360°. In some embodiments, there aregreater or fewer than three leaflets, and the angled course variesaccordingly. For example, a prosthetic valve may have four leaflets in aquadricuspid arrangement, with inflow edges each following an angledcourse of about 90°.

In the illustrated embodiment, the inflow edges 28 together define aplane that is generally perpendicular to the axis Z. As best seen inFIGS. 7 and 8, a hub 42 of the inflow edges 28 of the leaflets is atsubstantially the same longitudinal position as the edge portions 44thereof. In other embodiments (not illustrated), the hub 42 islongitudinally offset, for example, towards the inflow end 14 or outflowend 16 relative to the edge portions 44 of the inflow edges. Someembodiments in which the hub 42 is longitudinally offset exhibitimproved radial compressibility compared to similar prosthetic valves 10in which the central hub 42 is not longitudinally offset, for example,because the suture 36 and/or reinforcing fabric 38 are distributed overa greater longitudinal distance, resulting in less bunching. In someembodiments, at least one edge portion 44 is displaced longitudinally.

In some embodiments in which the hub 42 is offset towards the inflow end14, the central hub 42 extends farther upstream than any portion of theframe 12. In other embodiments, the hub 42 and the most upstream portionof the frame 12 have substantially the same longitudinal position. Inother embodiments, the hub 42 is disposed downstream of the mostupstream portion of the frame 12. As discussed in greater detail below,some embodiments of the inflow edges 28 are equipped with additionalsupport members. In some embodiments, one or more portions of the inflowedge 28, for example, the hub 42 is suspended from the frame 12 in theradially expanded configuration, for example, using suture, thread,fibers, or wire.

Some embodiments of the hub 42 are offset radially from the center ofthe frame 12, for example, where the frame is non-circular, for example,oval or D-shaped, and/or where an offset flow axis is desired. Theradial offset is combinable with a longitudinal offset of the hub 42and/or edge portion(s) discussed above.

As best shown in FIGS. 1 and 3, the articulating edges 30 may eachfollow a contoured course, with an apex approximately half-way betweenthe commissure tabs 22 of each of the leaflets 20. Alternatively, theapex of an articulating edge 30 can be located closer to one of the twocommissure tabs 22 than the other.

In various embodiments, instead of having a single curved articulatingedge 30, one or more of the leaflets 20 can multiple articulating edges,depending upon the shape of the leaflets 20, such as two, three or fourarticulating edges. Thus, in some embodiments, the leaflets 20 can bepolygonal-shaped, with a single inflow edge 28 and multiple articulatingedges, such as two, three, four or five articulating edges. In someembodiments, the articulating edges 30 are free edges (i.e., noconnected structures), whereas in other embodiments, the articulatingedges 30 are connected to cord(s) or other structures. In someembodiments, one or more of the leaflets 20 has a combination of freeand non-free articulating edges 30.

FIG. 1 shows the outflow end of the prosthetic valve 10 in an openconfiguration, with the articulating edges 30 located in a radiallyinward position and the outflow surfaces 26 facing each other. In thisconfiguration, blood can flow through multiple discrete areas 34 (FIGS.3-4) located between the frame 12 and the leaflets 20. As shown in FIGS.3-4, the prosthetic valve in an open configuration can form athree-spoke-wheel or an encircled three-pointed star arrangement (i.e.,similar to a Mercedes-Benz® logo), as viewed from either end 14, 16 ofthe prosthetic valve. Even though the leaflets 20 are collapsed by theforward blood flow into this radially inward collapsed position, avestigial or reduced pocket 32 can remain between the leaflets 20,facing the outflow direction and bordered by the articulating edges 30and the outflow surfaces 26. This pocket 32 can be configured to captureany reverse blood flow (i.e., flow towards the inflow direction) or backpressure that may occur subsequent to the passage of a pulse of forwardblood flow. Blood flow or pressure thus entering into the pocket 32 canexert force on the outflow surfaces 26, thereby pushing each leaflet 20radially outward, with the articulating edges 30 spread radially aparttowards the frame 12 to close the prosthetic valve 10. In oneembodiment, as shown in FIGS. 1 and 3, the pocket 32 can besubstantially triangular-shaped. In various other embodiments, thispocket 32 can assume various other shapes, depending upon the number andorientation of leaflets in the prosthetic valve, such as a rectangular,square or other polygonal shape. In some embodiments, the inflowsurfaces 24 can be concave in the open and/or the closed configurations.Likewise, in some embodiments, the outflow surfaces 26 can be convex inthe open and/or the closed configurations.

FIGS. 6-7 show the prosthetic valve 10 in a closed configuration, withthe leaflets 20 forced fully outward. In this configuration, thearticulating edges 30 can be spread maximally apart, such that eacharticulating edge 30 is in contact with the frame 12 and/or the skirt18. As shown, interiors of the leaflets 20 can be substantiallyco-planar, such that the interiors of the leaflets 20 generally lie in aplane that is substantially perpendicular to the longitudinal axis Zwith some puckering or cupping of the leaflet. As such, the leaflets 20can extend radially outwards to cover the outflow facing sides of thecommissure tabs 22, as shown in FIG. 6. The articulating edges 30 caneach extend to contact the skirt 18 and/or the frame 12, thus effectingclosure of the prosthetic valve 10.

In the illustrated embodiment, the leaflets 20 are oversized such thatthe articulating edges 30 define an upturned rim 46 (FIG. 2) extendingtowards the outflow end 16, the rim 46 coapting with or sealing againstthe skirt 18, thereby preventing backflow of blood or fluid. Theoversizing also allows the leaflets 20 to accommodate deployment in anon-circular native valve annulus, in which the frame 12 assumes anon-circular cross-sectional shape, in some embodiments. In this closedposition, the outflow surfaces 26 can generally face the outflow end 16,and the inflow surfaces 24 can generally face the inflow end 14. Thus,in some embodiments, no discernible pocket may remain between theleaflets 20 in the closed configuration.

In some embodiments, the leaflets 20 at least partially overlap in theclosed configuration, such that the inflow surface 24 of one leaflet canat least partially cover the outflow surface 26 of another leaflet. Inother embodiments, the leaflets 20 do not significantly overlap in theclosed configuration.

In some embodiments, all of the leaflets 20 are formed from a singlesheet (or other single piece) of leaflet material. FIG. 8 shows anexemplary unitary sheet of leaflet material forming three leaflets 20connected side-by-side in a flattened configuration. The leaflets 20 canhave scalloped articulating edges 30 and straight inflow edges 28. Inother embodiments, the inflow edges 28 and/or articulating edges 30independently have another shape, for example, convex, concave, arcuate,and/or angled. In particular, the articulating edges 30 are suitablyshaped in embodiments in which the hub 42 is radially offset and/or theframe 12 is non-circular. The opposite ends of the sheet can be securedtogether to form a tubular configuration. The sheet of leaflet materialcan then be folded to form the three leaflets 20, with the inflow edges28 joined together as described herein such that the leaflets 20 canassume their operating configurations.

Alternatively, instead of folding a unitary sheet to form the leaflets,the sheet of leaflet material can be cut to form three separate leaflets20, which can then be secured to each other in the matter describedabove and shown in the figures. In another embodiment, the leaflets 20are each cut separately from a sheet of leaflet material, at adjacentand/or non-adjacent locations along the sheet of leaflet material.

The leaflets 20 can be formed of pericardial tissue (e.g., bovinepericardial tissue), biocompatible synthetic materials, or various othersuitable natural or synthetic materials as known in the art anddescribed in U.S. Pat. No. 6,730,118, which is incorporated by referenceherein. In one embodiment, the leaflets 20 are sutured together, and athin fabric (such as woven PET) or tissue material is wrapped (orotherwise placed) atop the sutured areas during manufacture to hold theleaflets 20 securely in place and/or to prevent cutting of the leafletmaterial. The tissue or fabric may be biocompatible, such that it canremain in this position when implanted.

In the illustrated embodiment, the inflow edges 28 are joined togetherwithout incorporating any additional supporting members or framework. Inother words, the inflow edges 28 of the valve 10 are self-supporting.Other embodiments (not illustrated) include at least one or moreadditional supporting members at the inflow edges 28, for example,struts or beams. The additional supporting member(s) can be internal,for example, enclosed by the leaflets 20 and/or reinforcing layer 38, orexternal, for example, exposed. Some embodiments of the additionalsupporting member(s) are coupled directly to the frame 12, while otherembodiments are coupled to the frame indirectly through the leaflets 20and/or reinforcing layer 38. Some embodiments of the additionalsupporting member(s) independently comprise one or more materialsdiscussed below as frame materials. In some embodiments, the additionalsupport members include guy wires, thread, fiber, or suture extendingbetween selected locations of the inflow edges, for example, the hub 42and the frame 12, for example, the inflow end 14.

The skirt 18 can comprise a thin, flexible sheet of material, and can bemade of any of various suitable materials, such as a fabric (e.g.,polyethylene terephthalate (PET) (sold under the tradename DACRON®),ultra-high-molecular-weight polyethylene (UHMWPE) (sold under thetradename DYNEEMA PURITY®), etc.), tissue (e.g., pericardial tissue),PTFE, metal, sponge, or polymer. In the illustrated embodiment, theskirt 18 desirably extends the full length of the frame 12 from theinflow end 14 to the outflow end 16. In other embodiments, the skirt 18can extend less than the full length of the frame 12, such as from theinflow end 14 to a location on the frame at about the same axialposition of the articulating edges 30 of the leaflets in their openposition.

The frame 12 can be a collapsible and expandable annular frame that isconfigured to be collapsed to a radially collapsed state for mounting ona delivery apparatus and expanded to a radially expanded state insidethe body. The frame 12 can be configured such that, in the radiallyexpanded state, no frame component or mechanical strut/arm or otherappendage extends into lumen or extends radially inward toward thecentral longitudinal axis of the frame.

As used herein, the term “annular” can refer to a frame having anyclosed shape in cross-section (taken along a plane perpendicular to thelongitudinal axis Z), including but not limited to a circular/ringshape, or a square/rectangular shape, a polygonal shape, a trefoil, orelliptical shape. Likewise, an annular frame can have variousthree-dimensional structures, including but not limited to a cylindricalstructure (as shown in the figures) or a non-cylindrical tubularstructure having a cross-sectional profile (taken along a planeperpendicular to the longitudinal axis Z) that varies along its length.As shown in FIGS. 1 and 2, the frame 12 can comprise a plurality ofcircumferential rows of zig-zag struts, connected by longitudinalstruts. U.S. Pat. No. 7,993,394, hereby incorporated by reference in itsentirety, provides additional description of various frame embodimentsthat can be used in the prosthetic valve embodiments disclosed herein.The frame 12 can also be non-collapsible and/or non-expandable, such asfor surgical implantation.

In certain embodiments, the frame 12 can be made of any of varioussuitable plastically-expandable materials or self-expanding materials(e.g., a nickel-titanium alloy, such as Nitinol) as known in the art.Suitable plastically-expandable materials that can be used to form theframe 12 include, without limitation, stainless steel, a nickel-basedalloy (e.g., a nickel-cobalt-chromium alloy), polymers, or combinationsthereof. In particular embodiments, frame 12 is made of anickel-cobalt-chromium-molybdenum alloy, such as UNS R30035 (covered byASTM F562-02), commercially available as MP35N® (SPS Technologies),which comprises 35% nickel, 35% cobalt, 20% chromium, and 10%molybdenum, by weight. When the frame 12 is constructed of aplastically-expandable material, the prosthetic valve 10 can be crimpedto a radially compressed state on a balloon (or other expansion device)of a delivery apparatus.

The prosthetic valve embodiments disclosed herein can be surgicallyimplanted and/or can be delivered using a delivery apparatus, such as acatheter. The delivery apparatus can be inserted into the patient'svasculature and advanced through the patient's body using knowntechniques. In one implementation, the prosthetic valve is delivered ina transfemoral procedure in which the delivery apparatus is insertedinto a femoral artery and advanced through the aorta to the nativeaortic valve (or another native valve of the heart). In anotherimplementation, the prosthetic valve can be delivered in atransventricular procedure in which the delivery apparatus is insertedthrough a small surgical opening in the chest and another surgicalopening in the wall of the left ventricle of the heart, such as anopening made at the bare spot on the lower anterior ventricle wall. Inanother implementation, the prosthetic valve can be delivered in atransaortic procedure in which the delivery apparatus is insertedthrough a small surgical opening in the chest and another surgicalopening in the ascending aorta, at a location above the aortic valve. Inanother implementation, the prosthetic valve is a replacement venousvalve for implantation in a vein, or a replacement for another valvewith a lower flow rate relative to the aortic valve.

When the prosthetic valve is positioned at the desired deploymentlocation (e.g., within the native aortic valve), the balloon of thedelivery apparatus can be inflated to radially expand the prostheticvalve. In one embodiment, upon full expansion of the prosthetic valve10, the skirt 18 can be forced into contact with the surrounding tissueof the native valve, establishing a seal between the outer surface ofthe frame 12 and the surrounding tissue.

When constructed of a self-expanding material, the prosthetic valve canbe crimped to a radially compressed state and restrained in thecompressed state by insertion into a sheath or equivalent mechanism of adelivery catheter. After the delivery apparatus is inserted into thebody and advanced to position the prosthetic valve at the desireddeployment location, the prosthetic valve can be advanced from thedelivery sheath. As the prosthetic valve is deployed from the deliverysheath, the prosthetic valve can radially self-expand to its functionalsize.

It should be noted that the other embodiments of prosthetic valvesdisclosed herein can also be made from any of the plastically-expandableor self-expanding materials described above and can be implanted in theheart utilizing any of the delivery apparatuses and/or deliverytechniques described above in connection with prosthetic valve 10.

In alternative embodiments, the prosthetic valve can be a surgicallyimplanted prosthetic valve comprising a non-radially compressible andexpandable frame on which the leaflets 20 are mounted in the arrangementshown in the drawings.

General Considerations

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatuses, and systems are not limited toany specific aspect or feature or combination thereof, nor do thedisclosed embodiments require that any one or more specific advantagesbe present or problems be solved.

Features, integers, characteristics, compounds, chemical moieties orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods. Asused herein, the terms “a”, “an”, and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A”, “B,”, “C”, “A and B”, “A and C”, “Band C”, or “A, B, and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In view of the many possible embodiments to which the disclosedprinciples may be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather, the scope is defined bythe following claims. We therefore claim all that comes within the scopeand spirit of these claims.

We claim:
 1. A prosthetic valve comprising: an annular frame having aninflow end, an outflow end, and a longitudinal axis extending from theinflow end to the outflow end, wherein the annular frame is configuredto be collapsed to a radially collapsed state for mounting on a deliveryapparatus and expanded to a radially expanded state inside a patient'sbody; and a valve member mounted within the annular frame comprising aplurality of at least three flexible leaflets, each leaflet comprisingan inflow surface, an outflow surface, an inflow edge, and anarticulating outflow edge, wherein adjacent leaflets are affixed to oneanother along their respective inflow edges, wherein when the prostheticvalve is deployed within the patient's body: the forward flow of bloodthrough the prosthetic valve causes the leaflets to collapse radiallyinward to a collapsed state, defining an open configuration of theprosthetic valve, thereby creating a plurality of discrete flow areasbetween the frame and the inflow edges of the leaflets and a centrallylocated pocket facing the outflow end, wherein the pocket is defined bynon-contacting portions of the outflow edges of the leaflets at a centerof the valve member; and the reverse flow of blood enters the pocket andcauses the leaflets to be pushed radially outward, defining a closedconfiguration of the prosthetic valve, thereby closing the plurality ofdiscrete flow areas.
 2. The prosthetic valve of 1, wherein each of theinflow edges extend between two points spaced circumferentially apartalong an interior circumference of the frame, wherein the inflow edgesof the adjacent leaflets are joined together directly without the aid ofa mechanical support member extending between the points.
 3. Theprosthetic valve of claim 1, wherein, in the open configuration, theinflow edges of the leaflets form a three-pointed star arrangement asseen viewed along the longitudinal axis from the inflow end to theoutflow end.
 4. The prosthetic valve of claim 1, wherein, in the closedconfiguration, the outflow edges are in contact with the frame and/or askirt lining an interior surface of the frame.
 5. The prosthetic valveof claim 1, wherein in the closed configuration, the outflow surfacesface the outflow end, and the inflow surfaces face the inflow end. 6.The prosthetic valve of claim 1, wherein the prosthetic valve isconfigured to be deployed within the patient's heart.
 7. The prostheticvalve of claim 1, further comprising a skirt lining an interior surfaceof the annular frame.
 8. The prosthetic valve of claim 1, wherein anouter surface of the prosthetic valve is configured to seal againstsurrounding tissue to prevent blood from flowing between the inflow endand the outflow end along the outer surface of the prosthetic valve whenthe prosthetic valve is deployed within the patient's body.
 9. Theprosthetic valve of claim 1, further comprising an outer skirt securedaround an outside of the annular frame.
 10. The prosthetic valve ofclaim 1, further comprising a reinforcing fabric layer wrapped aroundjoined portions of the inflow edges and sutures passing through thefabric layer and the inflow edges.
 11. A prosthetic valve comprising: anannular frame having an inflow end, an outflow end, and a longitudinalaxis extending from the inflow end to the outflow end, wherein theannular frame is configured to be collapsed to a radially collapsedstate for mounting on a delivery apparatus and expanded to a radiallyexpanded state inside a patient's body; and a valve member mountedwithin the annular frame and comprising a plurality of at least threeflexible leaflets, wherein each leaflet comprises a straight inflow edgeand an articulating outflow edge that has a convex curved shapeprojecting in a downstream direction extending away from the inflow edgeand toward the outflow end of the frame; wherein when the prostheticvalve is deployed within the patient's body: the forward flow of bloodthrough the prosthetic valve causes the leaflets to collapse radiallyinward to a collapsed state, defining an open configuration of theprosthetic valve, thereby creating a plurality of discrete flow areasbetween the frame and the inflow edges of the leaflets; and the reverseflow of blood causes the leaflets to be pushed radially outward,defining a closed configuration of the prosthetic valve, thereby closingthe plurality of discrete flow areas.
 12. The prosthetic valve of claim11, wherein each leaflet comprises two tabs disposed at opposite ends ofthe inflow edge, wherein adjacent tabs of adjacent leaflets are securedto each other to form commissures of the leaflets and wherein theoutflow edge extends from adjacent commissures in the downstreamdirection.
 13. The prosthetic valve of claim 11, further wherein: eachof the inflow edges extend between two points spaced circumferentiallyapart along an interior circumference of the frame; and wherein theinflow edges of adjacent leaflets are joined together directly withoutthe aid of a mechanical support member extending between the points. 14.The prosthetic valve of claim 11, wherein the inflow edges lie in aplane perpendicular to the longitudinal axis.
 15. The prosthetic valveof claim 11, wherein the inflow edge of each leaflet has portionsaffixed to portions of the inflow edges of two other leaflets.
 16. Theprosthetic valve of claim 11, further comprising sutures joiningadjacent portions of the inflow edges of adjacent leaflets to eachother.
 17. A prosthetic valve comprising: an annular frame having aninflow end, an outflow end, and a longitudinal axis extending from theinflow end to the outflow end, wherein the annular frame is configuredto be collapsed to a radially collapsed state for mounting on a deliveryapparatus and expanded to a radially expanded state inside a patient'sbody; a valve member mounted within the annular frame and comprising aplurality of at least three flexible leaflets, wherein each leafletcomprises an inflow edge and an articulating outflow edge; and areinforcing layer wrapped around joined portions of the inflow edges andsutures passing through the reinforcing layer and the inflow edges tosecure the inflow edges of the leaflets to each other; wherein when theprosthetic valve is deployed within the patient's body: the forward flowof blood through the prosthetic valve causes the leaflets to collapseradially inward to a collapsed state, defining an open configuration ofthe prosthetic valve, thereby creating a plurality of discrete flowareas between the frame and the inflow edges of the leaflets; and thereverse flow of blood causes the leaflets to be pushed radially outward,defining a closed configuration of the prosthetic valve, thereby closingthe plurality of discrete flow areas.
 18. The prosthetic valve of claim17, wherein each leaflet comprises two tabs disposed at opposite ends ofthe inflow edge, wherein adjacent tabs of adjacent leaflets are securedto each other to form commissures of the leaflets.
 19. The prostheticvalve of claim 18, further comprising sutures joining the commissures toat least one of the annular frame and an inner skirt secured to an innersurface of the frame.
 20. The prosthetic valve of claim 19, wherein theoutflow edge of each leaflet comprises a convex curve extending from onecommissure to an adjacent commissure.